MAUDE Adverse Event Report: COVIDIEN SONICISION; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	SCDA39
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, eight dissectors had frequent alarm and still alarms after wiping and rinsing.Same situation when changing the second blade.The surgeon switched to another manufacturer.The dissector did not break.There was no patient injury.Medtronic's initial evaluation of the incident device found that the device's jaw disengaged, the broken jaw was returned.
Additional Manufacturer Narrative
D10 concomitant product: scda39, ultrason dissect scda39 curved jaw 39cm (lot#41910194x); scgaa, reusable generator a scgaa (serial#unknown); scba, battery scba (serial#unknown); scda39, ultrason dissect scda39 curved jaw 39cm (lot#41910194x); scda39, ultrason dissect scda39 curved jaw 39cm (lot#41910194x).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during procedure, 8 dissectors had frequent alarm and still alarms after wiping and rinsing.Same situation when changing the second blade.The surgeon switched to another manufacturer.The dissector did not break during procedure and did not fell inside the patient's cavity.There was no patient injury.Medtronic's initial evaluation of the incident device found that the device's jaw disengaged, the broken jaw was returned.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 (fdr).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SONICISION
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24590688
• Report Number: 1717344-2026-00365
• Device Sequence Number: 10114862
• Product Code: LFL
• UDI-Device Identifier: 10884521592841
• UDI-Public: (01)10884521592841(17)290708(10)41910194X
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SCDA39
• Device Catalogue Number: SCDA39
• Device Lot Number: 41910194X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 56 KG